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Effect of Oral Ice Chips to Prevent Chemotherapy-Induced Oral Mucositis in Patient With Solid Tumor Treated With 5 Fluorouracil and Methotrexate

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Mar 1, 2026 to Jul 15, 2026
    • Primary completion pushed from Aug 30, 2026 to Oct 30, 2026
    • Study completion pushed from Sep 30, 2026 to Nov 30, 2026
    v3
  2. Interventions: Experimental group will use ice chips and mouth wash (Other) to Oral Cryotherapy (Ice Chips) (Behavioral), Standard Oral Care (Mouthwash) (Behavioral)
    • Eligibility criteria shortened, about 3 words
    • Study title shortened, about 2 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this randomized controlled clinical trial is to determine whether oral cryotherapy using ice chips can prevent and reduce the incidence and severity of chemotherapy-induced oral mucositis in adult cancer patients receiving 5-fluorouracil and methotrexate chemotherapy regimens. The main questions it aims to answer are: Does the application of oral ice chips reduce the severity of oral mucositis compared to routine mouth care alone? Is there a significant difference in oral mucositis grades between patients receiving oral cryotherapy and those receiving standard mouthwash care? Researchers will compare the experimental group receiving oral ice chips during chemotherapy plus routine mouthwash care with the control group receiving routine mouthwash care only to evaluate the effectiveness of oral cryotherapy in reducing oral mucositis severity. Participants will: Be randomly assigned to either the experimental group (n = 51) or control group (n = 51) Receive chemotherapy with 5-fluorouracil or methotrexate Use routine mouthwash (normal saline/sodium bicarbonate/chlorhexidine) at home Receive oral ice chips during chemotherapy infusion (experimental group only) Be assessed for oral mucositis severity using the WHO Oral Mucositis Grading Scale before and after the intervention
Trial Details
NCT Number NCT07327476
Lead Sponsor University of Health Sciences Lahore
Conditions
(from sponsor)		 Chemotherapy Induced Oral Mucositis
Related terms Stomatitis
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov